Blood vessel cutter

ABSTRACT

A cutter ( 300 ) adapted for making an aperture in a blood vessel ( 810 ) suitable for receiving an anastomotic connector, the cutter comprising a handle a curved element extending from the handle, a sharp tip ( 306 ) at the end of the element, the tip ( 306 ) adapted for making at least one entry cut in a blood vessel ( 810 ) and at least one exit cut in the same blood vessel a distance from the entry cut while a portion of the curved element is substantially within the vessel lumen and a sharp edge ( 376 ) along a portion of the convex aspect of the portion, the edge adapted to cut the vessel as the handle is pulled radially away from the lumen.

RELATED APPLICATIONS

The present application claims priority from and is acontinuation-in-part of PCT application PCT/IL02/00790, filed on Sep.25, 2002, which designates the US, now published in English as WO03/026475, the disclosure of which is incorporated herein by reference.It also claims priority as well as the benefit under 119 (e) of U.S.Ser. No. 60/492,998, filed on Aug. 7, 2003. This application is also acontinuation-in-part of PCT/IL02/00215, filed on Mar. 18, 2002,PCT/IL01/01019, filed on Nov. 4, 2001, PCT/IL01/00903, filed on Sep. 25,2001, PCT/IL01/00600, filed on Jun. 28, 2001 and PCT/IL01/00266, filedon Mar. 20, 2001. The disclosure of all of these applications, whichdesignate the US and were filed in English, are incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates to devices used during hole-forming inblood vessels.

BACKGROUND OF THE INVENTION

Making an anastomotic connection between two vessels, for example, agrafted vessel and a coronary artery, bequeaths new life to a heart andthe human in which it beats.

To begin this life-saving operation, in a typical implementation, theoperator measures the host vessel to determine its diameter and choosesan anastomotic connector of a corresponding size. He cuts a linearaperture along the longitudinal axis of the host vessel, exactly to thesize of the connector. The operator then evaluates the incision lengthto ensure that it indeed has the precise length required. An improperhost vessel size evaluation and/or aperture length, can result in fatalconsequences, or at least, in some cases, in the need to close up oneincision and make another.

Surgery on life sustaining organs, often already weakened by theinadequate blood supply, demands speed to reduce surgical risks. Hence,all the steps required in forming a precision aperture, should occurwithin a relatively short period of time. Instruments that facilitateprecision vessel and aperture evaluation and/or rapid cutting of anaperture and/or simplify the process, can be useful in ensuring asuccessful anastomotic connection.

SUMMARY OF THE INVENTION

A broad aspect of some embodiments of the invention relates to ensuringthat an aperture formed in a blood vessel is of a desired length.Optionally, a device in accordance with an exemplary embodiment of theinvention assists in preventing over cutting of the aperture. Optionallyalternatively or additionally, a device in accordance with an exemplaryembodiment of the invention is inserted into a blood vessel to begin anincision and may be removed while having caused only minimal damage tothe vessel, which does not require stitching shut, for example, only asmall puncture wound.

An aspect of some embodiments of the invention relates to a cutterinstrument that cuts an aperture in a blood vessel. In an exemplaryembodiment, the cutter comprises a post having a curved element with asharp tip extending from the post, a portion of the convex aspect of thecurved element comprising a sharp edge.

In an exemplary embodiment, the tip pierces through a host vessel wall,making an entry puncture. In some embodiments, the tip makes a small cutrather than a puncture. In either case, the tip is optionally designedto prevent tearing and/or forming of a large aperture. The post ismanipulated until the tip exits the blood vessel, making an exitpuncture at a distance from the entry puncture while a portion of theelement moves through the vessel lumen. As only the convex aspect of thecutter is sharp, no damage is caused to the blood vessel beyond thesetwo cuts. In an exemplary embodiment of the invention, the entrymanipulation is assisted by the curved element being substantially anarc. By pulling the element radially away from the vessel lumen, thesharp convex edge cuts the portion between the entry and exit cuts,joining the two cuts into a single aperture. Alternatively, if thedistance between the entry and exit puncture is not a desired incisionlength, the cutter may be removed and/or manipulated so that a new exitpuncture is made, at a correct distance.

Optionally, markings are provided on the cutter to assist in estimatingthe expected incision length. For example, the convex edge comprises afirst entry marking a first distance from the tip and a second entrymarking at a second distance from the tip. In an exemplary embodiment,an entry puncture into the vessel is made with the tip and the elementis manipulated in the blood vessel until the entry puncture is alignedwith either the first entry marking or the second entry marking.

The post is manipulated until the tip exits the blood vessel, making anexit puncture in the vessel and the cutter is pulled away from thevessel to make an aperture joining the exit puncture with the entrypuncture. When the entry puncture has been aligned with the first entrymarking, an aperture of a first length results. When the entry puncturehas been aligned with the second entry marking, an aperture of a secondlength results.

In an exemplary embodiment of the invention, the post and the opposingtip set the final length of the incision prior to completing theincision (when only two punctures, easily sealed, e.g., by simplepressure or a dab of adhesive, had been made). Any correction can bemade by advancing the post so the opposing tip is retracted into theblood vessel and then repositioning the tip. Alternatively oradditionally to setting the length, the post and tip set the exactlayout of the incision (e.g., orientation).

In an exemplary embodiment of the invention, the use of a curved cuttingedge allows focusing the cutting force on a small part of the vessel, ifnecessary. Optionally, the use of a curved cutting edge simplifies thecontrol of the position of the cutting edge, by rotating the post.Optionally, the use of a curved cutting edge provides relative motionbetween the edge and the tissue being cut, as it slides on the edge,possibly assisting in cutting. Optionally, the use of a curved cuttingedge focuses the force on a relatively short section of blood vesselwall, when the post is pulled back with greater force.

An aspect of some embodiments of the invention relates to a frame forcontrolling an incision length. In an exemplary embodiment of theinvention, the frame comprises a tip inserted into a blood vessel and aframe section that pinches a section of the blood vessel wall betweenthe tip and the frame, thereby ensuring that cutting (e.g., with ascalpel) can be easily limited to the portion of the blood vesselpinched by the frame and/or bounded by the frame on at least one side.

An aspect of some embodiments of the invention relates to a measurementdevice, optionally in the form of a slotted elongate ribbon that is usedin evaluating the diameter of a host vessel and/or in evaluating anaperture length cut in the vessel. In an exemplary embodiment, theribbon comprises at least one first slot, having a first opening length,extending across a portion of the ribbon width and at least one firstedge having a first dimension adapted for insertion into an aperture ina blood vessel.

In an exemplary embodiment, the at least one first slot is placed aroundthe blood vessel to evaluate whether the vessel is, for example, smallerthan the minimal size that can receive an anastomotic connector. Whenthe vessel is deemed to have an appropriate minimal diameter, anaperture length, of an appropriate length for the anastomotic connector,is cut into the host vessel using, for example, the cutter describedherein. Following cutting the aperture, the at least one first edge ofthe elongate ribbon is placed in or near the aperture to determine thatthe aperture has an appropriate length for the connector.

In an exemplary embodiment, the ribbon comprises multiple slots havingdifferent opening dimensions and the vessel is evaluated for receptionof two or more anastomotic connectors, each having a different diameter.Alternatively or additionally the ribbon comprises multiple edges havingmultiple lengths that are adapted to measure two or more aperturelengths in the host vessel.

In an exemplary embodiment of the invention, the measurement deviceincludes a marker for indicating a desired incision length and/orposition. In an exemplary embodiment of the invention, the measurementdevice includes, at one or both of the incision measurement edges, asponge (or a tissue adhesive) with ink Alternatively or additionally,the measurement device includes a surface suitable for absorbing oraccepting ink from a marker and then exuding said ink when in contactwith tissue. In use, the marker may be used to indicate a desiredincision length prior to cutting, instead of or before testing theincision by inserting the measurement device. Alternatively, the inkmarks the blood vessel when the marker is inserted into the incision,thereby marking alongside the incision the actual length of the marker.A cap is optionally provided to protect the marker section of themeasurement device, before use.

In an exemplary embodiment, a kit suitable for use during anastomoticsurgical procedures comprises at least one blood vessel cutter and atleast one blood vessel evaluator.

There is thus provided in accordance with an exemplary embodiment of theinvention, apparatus for forming an incision of a controlled size in ablood vessel, comprising:

a sterile penetration tip which is adapted to pierce a wall of the bloodvessel; and

an arcuate section having a cutting edge defined on an inner portionthereof, extending from said penetration tip. Optionally, said tip isadapted to pierce said wall without tearing. Alternatively oradditionally, said apparatus comprises a handle extending from saidarcuate section on an opposite said of said arcuate section.

In an exemplary embodiment of the invention, said arcuate sectiondefines at least one incision length marking thereon. Optionally, saidarcuate section defines at least two incision length marking thereon.

In an exemplary embodiment of the invention, said tip, arcuate sectionand handle lie in a plane.

In an exemplary embodiment of the invention, apparatus includes acutting edge only on said arcuate section on an inner portion thereof.

In an exemplary embodiment of the invention, a non-cutting section isdefined between a forward tip of said penetration tip an said cuttingedge, said separation being greater than 0.5 mm.

In an exemplary embodiment of the invention, said cutting edge has alinear extent of less than 20 mm.

In an exemplary embodiment of the invention, said cutting edge has alinear extent of less than 10 mm.

In an exemplary embodiment of the invention, said cutting edge has alinear extent of less than 5 mm.

There is also provided in accordance with an exemplary embodiment of theinvention, apparatus for forming an incision of a controlled size in ablood vessel, comprising:

a sterile penetration tip which is adapted to pierce a wall of the bloodvessel; and

a body extending from said tip; and

a cutting guide defined on said body. Optionally, said apparatuscomprises a frame adapted to lock said wall between said frame and saidbody, from outside the blood vessel. Alternatively or additionally, saidcutting guide comprises a slot sized to receive a cutting blade suitablefor cutting blood vessel walls. Optionally, said slot is marked withdistance markers. Alternatively or additionally, said slot has a far endat a point less than 20 mm from said penetration tip. Optionally, saidslot has a far end at a point less than 10 mm from said penetration tip.

In an exemplary embodiment of the invention, said frame is attached tosaid body by a hinge. Alternatively or additionally, said framecomprises a cutting stop adjacent said penetration tip and past an endof said cutting guide.

In an exemplary embodiment of the invention, said penetration tip isadapted to pierce said blood vessel without causing a tear.

In an exemplary embodiment of the invention, said body is straight.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of forming an incision in a blood vessel,comprising:

(a) inserting a penetration tip into a blood vessel, forming a puncture;

(b) fixing said penetration tip so that it maintains a fixed axialposition relative to an axis of the blood vessel; and

(c) cutting a linear aperture guided by an extension of said penetrationtip.

Optionally, fixing comprises penetrating said penetration tip out ofsaid blood vessel. Alternatively or additionally, fixing compriseslocking said blood vessel to said extension of said tip using a frame onthe outside of the blood vessel.

In an exemplary embodiment of the invention, the method comprisesdetermining an expected incision length prior to said cutting.Optionally, the method comprises said fixing if said expected length isnot a desired length.

In an exemplary embodiment of the invention, the method comprisesremoving said penetration tip and repeating (a)-(b) to achieve a desiredexpected incision length.

In an exemplary embodiment of the invention, comprises comprisingretracting said extension to form a cut. Alternatively, cuttingcomprises guiding a knife along said penetration tip to form a cut.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of cutting an incision in a blood vessel,comprising:

(a) inserting a front tip of a sickle shaped cutter into a blood vessel;

(b) manipulating said tip to exit the blood vessel at a different point;and

(c) retracting said sickle shaped cutter to cut the blood vessel.Optionally, the method comprises repositioning said tip prior to saidretracting, to exit said blood vessel at a further different point.Alternatively or additionally, said blood vessel is only punctured bysaid tip and is not damaged in any other way by the sickle cutter, priorto (c).

There is also provided in accordance with an exemplary embodiment of theinvention, an evaluator adapted for evaluating a blood vessel,comprising:

a flat elongate element having a width;

at least two slots of different opening sizes extending through aportion of the width and adapted to receive a blood vessel therein;

at least one first edge gauge along the element, the edge gauge having afirst dimension,

wherein said first dimension is of an incision length in a side vesselsuitable for an end-to-side anastomotic connection using an evertedblood vessel having the diameter between the two opening sizes.Optionally, the evaluator includes at least one third slot extendingthrough a portion of the width, the at least one third slot having anopening of a size greater than the other two slots. Optionally, theevaluator includes at least one second gage edge, the edge having asecond dimension of an incision length in a side vessel suitable for anend-to-side anastomotic connection using an everted blood vessel havingthe diameter between the greater size and the two opening sizes.

In an exemplary embodiment of the invention, the evaluator includes amarking section adapted for marking a blood vessel, said marking sectionbeing at said end gauge. Optionally, said marking section is at an edgeof said end gauge.

There is also provided in accordance with an exemplary embodiment of theinvention, a sterilized marking evaluator adapted for evaluating a bloodvessel comprising:

a flat elongate element having a width;

at least one first edge gauge along the element, the edge gage having afirst dimension; and

a marking section adapted for marking a blood vessel, said markingsection being at or near said end gauge. Optionally, said firstdimension is smaller than 6 mm.

In an exemplary embodiment of the invention, said marking section is atan edge of said end gauge.

Optionally, said evaluator comprises a cap to protect said markingsection when not in use.

In an exemplary embodiment of the invention, said evaluator comprises asecond edge gauge with a second dimension and a second marking sectionthereat.

In an exemplary embodiment of the invention, said marking section is atsaid end. Alternatively, said marking section is near said end.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of cutting an aperture in a blood vessel,comprising:

contacting said vessel with a marker having a fixed marking length; and

cutting along said marking. Optionally, the method comprises measuring afinished aperture with said marker. Alternatively or additionally, themethod comprises inking said fixed marking width prior to saidcontacting.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of cutting an aperture in a blood vessel,comprising:

inserting a penetration tip into a blood vessel at a point;

visually identifying on the blood vessel a desired incision, starting atsaid point; and

cutting according to said visual guiding.

BRIEF DESCRIPTION OF THE FIGURES

Non-limiting embodiments of the invention will be described withreference to the following description of exemplary embodiments, inconjunction with the figures. The figures are generally not shown toscale and any sizes are only meant to be exemplary and not necessarilylimiting. In the figures, identical structures, elements or parts thatappear in more than one figure are preferably labeled with a same orsimilar number in all the figures in which they appear, in which:

FIG. 1 is a side view of a vessel evaluator, in accordance with anexemplary embodiment of the invention;

FIG. 2 is side view of a blood vessel cutter, in accordance with anexemplary embodiment of the invention;

FIGS. 3A-3D are views of the blood vessel cutter of FIG. 2, cutting anaperture in a blood vessel, in accordance with an exemplary embodimentof the invention;

FIG. 4 shows the vessel evaluator of FIG. 1 being used in evaluating anaperture in a blood vessel;

FIG. 5 is a schematic illustration of a marking end of a markingevaluation gauge, in accordance with an exemplary embodiment of theinvention; and

FIGS. 6A and 6B illustrate a frame-type incision controller, inaccordance with an exemplary embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Blood Vessel Evaluator

FIG. 1 is an isometric view of a vessel evaluator 200, used inevaluating the diameter of blood vessel 810, (FIG. 3B) in accordancewith an exemplary embodiment of the invention. Evaluator 200 comprisesnotches 210, 220 and 230 that are used to measure the diameter of bloodvessel 810 and determine whether a larger or smaller aperture andcorresponding anastomotic connector is appropriate.

In an exemplary embodiment, notch 220, having a diameter, for example of3.5 millimeters, is placed around the blood vessel. If the vessel 810diameter fits into notch 220, smaller notch 210 is placed around vessel810. If vessel 810 is larger than smaller notch 210, vessel 810 has adiameter of between 2.0 and 3.5 millimeters, appropriate for an apertureand connector, for example, of 2.5 millimeters.

If, on the other hand, vessel 810 does not fit into notch 220, largernotch 230 is placed around vessel 810. If vessel 810 fits into largernotch 230, it has a diameter between 3.5 and 6.0 millimeters andappropriate for an aperture and connector, for example of 2.9millimeters. In practice, an anastomosis kit may be provided with onlytwo (or other small number, such as three or four) sizes of connectors,small and large. Size small, uses vessels between the sizes of notches210 and 220 and size large uses vessels between the sizes of notches 220and 230. An incision evaluator described below may also be calibratedfor these two sizes.

When vessel 810 is larger than larger notch 230 or smaller than smallernotch 210 it is rejected as a graft vessel. In such instances, forexample, another graft vessel having an appropriate diameter is sought.

Thus, in an exemplary embodiment of the invention, by using evaluator200, an operator can rapidly determine the range of the size of vessel810 and choose an appropriate connector and corresponding incisionlength.

Blood Vessel Cutter

FIG. 2 is a side view of a blood vessel cutter 300 having an overall “J”shape that is appropriate for cutting an incision along a longitudinalaxis of vessel 810 (FIG. 3D), in accordance with an exemplary embodimentof the invention. Cutter 300 comprises a post 346 from which a curvedblade 302 with a sharp tip 306 project. Typically a portion of curvedblade 302 comprises a diameter formed around an origin 380 and a sharpconvex edge 376. While a perfect arc is not required, for example apiece-wise section or a non-arc curve may be used, an arc section mayhave the advantage of easy manipulation as described below.

FIGS. 3A-3D demonstrate operation of cutter 300. Tip 306 is pressedagainst a surface of blood vessel 810 to make entry cut 340. In anexemplary embodiment of the invention, the cut is actually a smallpuncture, possibly with no tearing beyond a pinprick. Blade 302 isrotated and/or manipulated, generally in a direction 310. In anexemplary embodiment of the invention, this rotation is assisted byblade 302 being arcuate and not having a cutting edge on its outercurve, as in some embodiments of the invention. FIG. 3C shows tip 306making an exit cut (or hole) 330. Optionally, an exit marking 334 neartip 306 is provided which can be visualized by the operator. Marking 334allows the surgeon to determine that tip 306 has fully pierced bloodvessel 810 and/or that cutter 300 will not displace inappropriatelyduring cutting.

In FIG. 3D, cutter 300 is then pulled in a direction 312 so that sharpedge 376 cuts the distance between entry cut 340 and exit cut 330.

In an exemplary embodiment, a surgical kit is provided with a firstcutter 300 having a first diameter, appropriate for creating an apertureof a first size and a second cutter 300 having a diameter appropriatefor creating an aperture of a second size. Alternatively oradditionally, a single cutter 300 is provided that can be used to createat least two apertures of different sizes.

In an exemplary embodiment, cutter 300 comprises exit marking 334, afirst entry marking 342 a first distance 384 from marking 334 and asecond entry marking 344 a second distance 386 from marking 334.

After tip 306 has made entry cut 340 (FIG. 3C), blade 302 ismanipulated, for example, so that a first entry marking 342 is alignedwith entry cut 340. The operator manipulates tip 306 so it exits vessel810, making exit cut 330 that he aligns with exit marking 334. When post346 is pulled in direction 312, aperture 222 of first length 384, forexample 2.5 millimeters, is formed.

In an exemplary embodiment, when a larger aperture and connector arerequired, exit marking 344 is aligned with exit cut 340 and entry cut330 is aligned with entry marking 344. When post 346 is pulled indirection 312, an aperture having a second length 386, for example 2.9millimeters, results. In some case, a physician may intentionallystretch or compress the blood vessel, for example during manipulation(FIG. 3B), resulting a differently sized incision. If a physician isfound to regularly and unintentionally modify the incision length, acutter with a suitably changed marking and/or geometry is provided.

Blood Vessel Cutter Specifications

Referring to FIG. 3A, while a radius 386 of the curve of blade 302 is,for example 2.9 millimeters, it could be as small as 2.6 millimeters forsmaller host vessels and anastomotic connectors and as large as 3.9millimeters for larger vessels and larger anastomotic connectors.

While distance 384, including two widths of blade 302, is 2.0millimeters, it could be as small as 1.4 millimeters, or less, such as1.2 millimeters for smaller host vessels and anastomotic connectors andas large as 2.9 millimeters for larger vessels and larger anastomoticconnectors. The thickness of blade 302, is, for example 0.4 mm and theblade may be smooth or serrated. In an exemplary embodiment of theinvention, tip 306 is rounded and needle like, so that it will not causetears. Rounding can be achieved, for example, using electro-polishing. Asection of non-cutting area, for example 0.5 mm, 1 mm or 2 mm isoptionally provided between the tip and the cutting area, to preventinadvertent cutting when tip 306 exits for the vessel wall.

Aperture Evaluator

In an exemplary embodiment, evaluator 200 (FIG. 1) comprises a first endedge 212 having a first measurement 213 of 2.5 millimeters and a secondend edge 222 having a second measurement 223 of 2.9 millimeters.

As seen in FIG. 4, end 212 is placed into aperture 222 and a snug fitindicates that aperture 222 is 2.25 millimeters (size “small”). For anaperture of 3 millimeters (size “large”), end 212 is placed intoaperture 222 and a snug fit indicates that aperture 222 is of anappropriate length. Thus the operator can proceed with making ananastomotic connection, assured that aperture 222 is of an appropriatelength.

If aperture 222 is shorter than necessary, it must be lengthened. Ifaperture 222 is longer than necessary, it must be closed to forgo, forexample, anastomotic connection at this site.

Evaluator Specifications

In an exemplary embodiment, handle 240 has a length 292 of 9 centimetersand a width 260 of 6.0 millimeters. Alternatively or additionally handle240 could have a length of between 6 and 12 centimeters and width 260 of4-8 millimeters depending on the vessel being evaluated and/or whetherthe procedure entails a fully exposed surgical field or a closedsurgical field accessed, for example, through a small incision.Additionally, large or smaller lengths are contemplated based upon, forexample, the procedure location and the access technique.

A first end 212 and a second end 222 have a projection distance 242 of1.5 centimeters and offsets 216 and 214 of 2.0 millimeters each. Again,depending upon the size of the vessel being evaluated and/or whether thesurgical field is open or closed, these measurements may be varied up ordown. Notches 210, 220 and 230 have, for example, a “u” shape,appropriate for receiving blood vessel 810.

In an exemplary embodiment, evaluator 200 and/or cutter 300 comprisematerials that are compatible with biologic tissue, for exampletitanium. Alternatively or additionally all edges are smoothed toprevent trauma to tissue associated with sharp edges.

Marking Evaluator

FIG. 5 is a schematic illustration of a marking end 501 of a markingevaluation gauge 500, in accordance with an exemplary embodiment of theinvention. A marking area 504 is adapted to apply ink to a wall ofvessel 810 (e.g., FIG. 4). In use, once a decision is made to create anincision, marking area 504 is used as a contact stamp to mark theprospective incision with ink. In one embodiment, a marker is used toapply ink to a suitably treated section of gauge 500, so that it willlater release the ink. In one embodiment, area 504 is a sponge oradhesive, or is rough, and ink is applied, for example with an ink pador by running a marker on it. For some markers and/or ink types, nospecial preparation of area 504 is required. In another embodiment, area504 already contains the ink and is optionally protected before use by acap 508. While a solid marking area is shown, in some embodiments, adifferent pattern is useful, for example, a set of ruled lines.

In an alternative embodiment, area 505 is a marker area, forming a frontedge 502 of end 501 and/or on one side thereof. Optionally, area 505 isV shaped, with its apex pointed towards edge 502.

Alternatively or additionally, end 501 is inserted into a formedincision and marking area 504 indicates on the outside of the vessel,the width of end 501, for easier comparison. In an exemplary embodimentof the invention, the forward surface of end 501 is flat edge 502, withsharp corners 506 such that it has a rectangular shape. Alternatively,corners 506 are rounded. Alternatively or additionally, edge 502 is Vshaped.

Cutting Frame

FIGS. 6A and 6B illustrate a cutting frame 600, used for controlling alength of incision in a target vessel 620, in accordance with anexemplary embodiment of the invention.

Frame 600 comprises a penetration section 602 which is inserted intoblood vessel 620, forming a puncture therein and having a puncture lip622. Optionally, penetration section 602 includes a sharp and/or hollowtip 604 to reduce trauma and/or tearing. Optionally, a slot 606 isformed in section 602 and is used for guiding a cutting instrument, asdescribed below. In the example shown, penetration section 602 is afront end of a shaft 616 which can also serve as a handle. Other designsare possible as well.

In addition, cutting frame 600 includes a frame 608 which can bearranged in a desired manner with respect to penetration section 602, aswill be described with reference to FIG. 6B. For convenience, in anexemplary embodiment of the invention, frame 608 is attached topenetration section 608 using a hinge 614. A back section 618 of frame608 is optionally closed to limit rotation of frame 608 in onedirection.

In an exemplary embodiment of the invention, cutting frame 600 providesone or both of the following functions: (a) a forward section 612 servesas a stop for a cutting instrument cutting along slot 606; and (b) frameside sections 610, which optionally couple forward section 612 to hinge608 lock a section of vessel 620, by pinching it between at least aportion of one or both of sides 610 and shaft 616, adjacent penetrationtip 602, so that the locked section does not change and the cutting isexact.

As can be seen in FIG. 6B, if a scalpel is used to cut along slot 606towards forward section 612, the length of the cut is fixed by thedistance between lip 622 and forward section 612. Optionally one or moremarkings 619 are provided adjacent slot 606, so that the final length ofan incision can be estimated before cutting is started. Optionallyalternatively or additionally, an end of the slot serves as a markingfor insertion depth of the penetration tip into the blood vesseloptionally, different length slots are provided for different desiredlengths. Then, in use, a knife can be inserted in the middle of the slotand used to cut both ways, towards the end of the slot and towards thepenetration tip.

If the length is incorrect, frame 608 can be released from penetrationsection 602 and penetration section 602 advanced into or retracted fromvessel 620, as needed, and then frame 608 locked again to penetrationsection 602, to prevent inadvertent changes in the incisionconfiguration.

In an alternative embodiment of the invention, cutter 300 is used as acutting guide, by cutting edge 376 being replaced by a slot and ascalpel or other blade guided along the slot. Alternatively, a scalpelcan be slid along the body of cutter 300, rather than in a slot.

Alternatively, cutter 300 provides a guillotine cut, in which a cuttingblade is guided by handle 346, from outside the blood vessel, towardscutting edge (or slot) 376. Similarly, a cutting edge may be attached tocutting frame 600, to be guided along slot 606.

In some embodiments, one or more of the devices, generally sterilize,described above, are packaged and/or sold with an instruction leaflet,describing the device dimensions and/or situations for which the deviceshould be applied. Also within the scope of the invention are surgicalkits comprising sets of medical devices suitable for making anastomoticconnections.

It should be appreciated that the above may be varied and still fallwithin the scope of the invention, for example, by changing the order ofsteps or by providing embodiments which include features from severaldescribed embodiments or by omitting features described herein. Sectionheadings where are provided are intended for aiding navigation andshould not be construed to limiting the description to the headings.

Measurements are provided to serve only as exemplary measurements forparticular cases. The exact measurements will vary depending on theapplication. When used in the following claims, the terms “comprises”,“comprising”, “includes”, “including” or the like means “including butnot limited to”.

A person skilled in the art will appreciate that the present inventionis not limited by what has thus far been described. Rather, the scope ofthe present invention is limited only by the following claims.

1. Apparatus for forming an incision of a controlled size in a bloodvessel, comprising: a sterile penetration tip which is adapted to piercea wall of the blood vessel; and an arcuate section having a cutting edgedefined on an inner portion thereof, extending from said penetrationtip, wherein said arcuate section defines at least one incision lengthmarking thereon.
 2. Apparatus according to claim 1, wherein said tip isadapted to pierce said wall without tearing.
 3. Apparatus according toclaim 1, comprising a handle extending from said arcuate section on anopposite end of said arcuate section.
 4. Apparatus according to claim 1,wherein said arcuate section defines at least two incision lengthmarkings thereon.
 5. Apparatus according to claim 1, wherein saidarcuate section defines at least two incision length markings,associated with different incision lengths, thereon.
 6. Apparatusaccording to claim 3, wherein said tip, arcuate section and handle liein a plane.
 7. Apparatus according to claim 1, said apparatus includes acutting edge only on said arcuate section on an inner portion thereof.8. Apparatus according to claim 1, wherein a non-cutting section isdefined between a forward tip of said penetration tip and said cuttingedge, said non-cutting section being longer than 0.5 mm.
 9. Apparatusaccording to claim 1, wherein said cutting edge has a linear extent ofless than 20 mm.
 10. Apparatus according to claim 1, wherein saidcutting edge has a linear extent of less than 10 mm.
 11. Apparatusaccording to claim 1, where said cutting edge has a linear extent ofless than 5 mm.
 12. Apparatus for forming an incision of a controlledsize in a blood vessel, comprising: a sterile penetration tip which isadapted to pierce a wall of the blood vessel; a body extending from saidtip; and a cutting guide defined an said body.
 13. Apparatus accordingto claim 12, comprising a frame adapted to lock said wall between saidframe and said body, from outside the blood vessel.
 14. Apparatusaccording to claim 12, wherein said cutting guide comprises a slot sizedto receive a cutting blade suitable for cutting blood vessel walls. 15.Apparatus according to claim 14, wherein said slot is marked withdistance markers.
 16. Apparatus according to claim 14, wherein said slothas a far end at a point less than 20 mm from said penetration tip. 17.Apparatus according to claim 14, wherein said slot has a far end at apoint less than 10 mm from said penetration tip.
 18. Apparatus accordingto claim 13, wherein said frame is attached to said body by a hinge. 19.Apparatus according to claim 13, wherein said frame comprises a cuttingstop adjacent said penetration tip and past an end of said cuttingguide.
 20. Apparatus according to claim 12, wherein said penetration tipis adapted to pierce said blood vessel without causing a tear. 21.Apparatus according to claim 12, wherein said body is straight.
 22. Amethod of forming an incision in a blood vessel, comprising: (a)inserting a penetration tip into a blood vessel, forming a puncture; (b)fixing said penetration tip so that it maintains a fixed axial positionrelative to an axis of the blood vessel; and (c) cutting a linearaperture guided by an extension of said penetration tip.
 23. A methodaccording to claim 22, wherein fixing comprises penetrating saidpenetration tip out of said blood vessel.
 24. A method according toclaim 22, wherein fixing comprises locking said blood vessel to saidextension of said tip using a frame on the outside of the blood vessel.25. A method according to claim 22, comprising, determining an expectedincision length prior to said cutting.
 26. A method according to claim25, comprising, removing said fixing if said expected length is not adesired length.
 27. A method according to claim 22, comprising, removingsaid penetration tip and repeating (a)-(b) to achieve a desired expectedincision length.
 28. A method according to claim 22, wherein cuttingcomprises comprising retracting said extension to form a cut.
 29. Amethod according to claim 22, wherein cutting comprises guiding a knifealong said penetration tip to form a cut.
 30. A method of cutting anincision in a blood vessel, comprising: (a) inserting a front tip of asickle shaped cutter into a blood vessel; (b) manipulating said tip toexit the blood vessel at a different point; (c) checking a marking onthe cutter to estimate a resulting incision length; and (d) retractingsaid sickle shaped cutter to cut the blood vessel, following thechecking.
 31. A method according to claim 30, comprising repositioningsaid tip prior to said retracting, to exit said blood vessel at afurther different point.
 32. A method according to claim 30, whereinsaid blood vessel is only punctured by said tip and is not damaged inany other way by the sickle cutter, prior to (d).
 33. An evaluatoradapted for evaluating a blood vessel, comprising: a flat elongateelement having a width; at least two slots of different opening sizesextending through a portion of the width and adapted to receive a bloodvessel therein; and at least one first edge gauge along the element, theedge gauge having a first dimension, wherein said first dimension is ofan incision length in a side vessel suitable for an end-to-sideanastomotic connection using an everted blood vessel having the diameterbetween the two opening sizes.
 34. An evaluator according to claim 33and including at least one third slot extending through a portion of thewidth, the at least one third slot having an opening of a size greaterthan the other two slots.
 35. An evaluator according to claim 34 andincluding at least one second gage edge, the edge having a seconddimension of an incision length in a side vessel suitable for anend-to-side anastomotic connection using an everted blood vessel havingthe diameter between the greater size and the two opening sizes.
 36. Anevaluator according to claim 33 and including a marking section adaptedfor marking a blood vessel, said marking section being at said endgauge.
 37. An evaluator according to claim 36, wherein said markingsection is at an edge of said end gauge.
 38. A sterilized markingevaluator adapted for evaluating a blood vessel comprising: a flatelongate element having a width; at least one first edge gauge along theelement, the edge gauge having a first dimension; and a marking sectionadapted for marking a blood vessel, said marking section being at ornear said edge gauge.
 39. A marking evaluator according to claim 38,wherein said first dimension is smaller than 6 mm.
 40. A markingevaluator according to claim 38, wherein said marking section is at anedge of said edge gauge.
 41. A marking evaluator according to claim 38,comprising a cap to protect said marking section when not in use.
 42. Amarking evaluator according to claim 38, comprising a second edge gaugewith a second dimension and a second marking section thereat.
 43. Amarking evaluator according to claim 38, wherein said marking section isnear said edge.
 44. A method of cutting an aperture in a blood vesselcomprising: contacting said vessel with a marker having a fixed markinglength; and cutting along said marking.
 45. A method according to claim44, comprising measuring a finished aperture with said marker.
 46. Amethod according to claim 44, comprising inking said fixed markinglength prior to said contacting.
 47. A method of cutting an aperture ina blood vessel, comprising: inserting a penetration tip into a bloodvessel at a point; visually identifying on the blood vessel a desiredincision, starting at said point; and cutting according to said visualguiding.